OTC MEVACOR GETS THUMBS DOWN AGAIN

Merck & Co
Inc's third bid for
OTC sales of the
cholesterol-lowering
drug Mevacor
(lovastatin) was
rejected by FDA
advisors. The company had previously
tried for OTC sales in 2000 and 2005.

Too many of the wrong individuals
would use the drug if it no longer
required a prescription, FDA advisors
concluded in a 10-2 vote December
13, 2007, against OTC sales. "The
patients couldn't figure out whether
the drug was for them," commented
one FDA advisor, William Shrank, MD.

The advisors also were surprised by
the results of a study of almost 1500
potential patients who wanted to purchase
the drug even though they were
bad candidates. Of the participants
who wanted the medication, 25% did
not have enough risk of heart disease
to qualify. The patients (30%) at very
high risk wanted Mevacor; these are
patients who should be under the care
of a physician.

Still, >30% of patients already taking
the prescription cholesterol-lowering
drug said they wanted an OTC version.
Half of the group said they would stop
the more potent drug in favor of lowdose
Mevacor. To the agency's advisors,
it raises questions about previously
protected patients setting themselves
up for a heart attack.

Merck's Edwin Hemwall, PhD, executive
director for the company's
worldwide nonprescription regulatory
and scientific affairs, said after the
meeting, "We are disappointed. We
felt we presented a compelling case."

The FDA is not required to follow its
advisors' recommendations but usually
follows them.